OLI · Fat Reducing Low Level Laser
General, Plastic Surgery · 21 CFR 878.5400 · Class 2
Overview
| Product Code | OLI |
|---|---|
| Device Name | Fat Reducing Low Level Laser |
| Regulation | 21 CFR 878.5400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Apr 15, 2026 | SESE |
| K243854 | Contour Light (CL-100) | Contour Research, LLC | Feb 13, 2026 | SESE |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | Dec 15, 2025 | SESE |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. | Dec 1, 2025 | SESE |
| K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | Jan 10, 2025 | SESE |
| K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | Nov 21, 2023 | SESE |
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | Jul 21, 2023 | SESE |
| K220519 | Erchonia Zerona Z-Bed | Erchonia Corporation | Mar 24, 2022 | SESE |
| K213534 | PHantom Trilogy | Resurgeonz, LLC | Mar 11, 2022 | SESE |
| K202955 | Contour Light CL-100 | Contour Research, LLC | May 19, 2021 | SESE |
| K202361 | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | Dec 18, 2020 | SESE |
| K192275 | invisa-RED ELITE | IR Technology, LLC | Aug 19, 2020 | SESE |
| K192544 | Erchonia Emerald | Erchonia Corporation | Jan 13, 2020 | SESE |
| K180338 | Cellulize | Ward Photonics, LLC | Sep 21, 2018 | SESE |
| K172111 | Vevazz LED | Vevazz, LLC | Nov 22, 2017 | SESE |
| K170709 | CURVE Laser System | Yolo Medical, Inc. | Jun 6, 2017 | SESE |
| K162578 | Zerona Z6 OTC | Erchonia Corporation | Dec 16, 2016 | SESE |
| K160880 | Photonica Professional | Ward Photonics, LLC | Sep 23, 2016 | SESE |
| K150446 | Erchonia Zerona 6 headed scanner EZ6 | Erchonia Corporation | May 21, 2015 | SESE |
| K143741 | Lipofina Laser System | Yolo Medical, Inc. | Apr 24, 2015 | SESE |
Top Applicants
- Erchonia Corporation — 13 clearances
- Ward Photonics, LLC — 3 clearances
- Contour Research, LLC — 2 clearances
- Erchonia Medical, Inc. — 2 clearances
- Yolo Medical, Inc. — 2 clearances
